Dental cleaning composition

ABSTRACT

Provided are dental cleaning compositions, methods of using and methods of using such compositions which minimize gum damage in the oral cavity. In one form, the dental cleaning composition includes a substantially stoichiometric ratio of one or more oxidizing agents to one or more reducing agents in one or more one or more orally acceptable carriers; where the substantially stoichiometric ratio of one or more oxidizing agents to one or more reducing agents is sufficient to neutralize the oxidizing agent in a subject oral cavity; and where the one or more oxidizing agents and one or more reducing agents are either co-dispensed or sequentially dispensed in the subject oral cavity.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application filed under 37 C.F.R.1.53(b) of parent application serial number U.S. Ser. No. 13/338,417,filed on Dec. 28, 2011, the entirety of which is hereby incorporatedherein by reference, which claims the benefit of provisional patentapplication Ser. No. 61/428,562 filed on Dec. 30, 2010, the disclosureof which is also incorporated by reference herein in its entirety.

BACKGROUND

1. Field

The present disclosure relates to the field of dental cleaning. It moreparticularly relates to novel dental cleaning compositions, methods ofmaking the compositions and methods of applying the compositions that donot damage the gums of the oral cavity. In particular, these benefitsare achieved by applying compositions comprising a combination of anoxidizing agent and a reducing agent in one or more orally acceptablecarriers which are either co-dispensed or sequentially dispensed.

2. Brief Description of Related Developments

The formation of dental plaque and calculus is the primary source ofdental caries, gingivitis, periodontal disease, and tooth loss. Dentalplaque is a mixed matrix of bacteria, epithelial cells, leukocytes,macrophages and other oral exudate. Bacteria comprise approximatelythree-quarters of the plaque matrix. Any given sample of dental plaquecould contain as many as 400 different varieties of microorganisms. Thismix includes both aerobic and anaerobic bacteria, fungi, and protozoa.Viruses have also been found in samples of dental plaque.

This matrix of organisms and oral exudate continues expanding andcoalesces with other plaque growths situated nearby. The bacteriasynthesize levans and glucans from sucrose found in the oral cavityproviding energy for the microorganisms. These glucans, levans, andmicroorganisms form an adhesive skeleton for the continued proliferationof plaque.

Dental calculus, or tartar, is a deposit which forms on the surfaces ofthe teeth at the gingival margin. Supragingival calculus appearsprincipally in the areas near the orifices of the salivary ducts; e.g.,on the lingual surfaces of the lower anterior teeth and on the buccalsurfaces of the upper first and second molars, and on the distalsurfaces of the posterior molars. Mature calculus consists of aninorganic portion which is largely calcium phosphate arranged in ahydroxyapatite crystal lattice structure similar to bone, enamel anddentine. An organic portion is also present and consists of desquamatedepithelial cells, leukocytes, salivary sediment, food debris and varioustypes of unless stained or discolored by some extraneous agent. Inaddition to being unsightly and undesirable from an aestheticstandpoint, the mature calculus deposits are constant sources ofirritation of the gingiva.

The failure to retard or stop the proliferation of plaque and calculusis detrimental to oral health. Plaque and calculus formation may lead todental caries, gingival inflammation, periodontal disease, andultimately tooth loss. Acidified dental preparations (pH lower than 7)have been shown to be good plaque and calculus dissolving agents.However, the potential damage of using regular organic or strong organicacids has kept them from being used in commercial products.Additionally, calculus and plaque along with behavioral andenvironmental factors lead to formation of dental stains, significantlyaffecting the aesthetic appearance of teeth. Behavioral andenvironmental factors that contribute to teeth staining propensityinclude regular use of coffee, tea, cola or tobacco products, and alsothe use of stain promoting oral products, such as chlorhexidine.

Conventional dental cleaning compositions typically contain aperoxide-bleaching agent in combination with a stabilizer and otheradditives. The stabilizer functions to inhibit the breakdown of theperoxide bleaching agent by slowing down the dissociation of theperoxide thereby prolonging its potency over a longer period of storageprior to use. The problem with conventional dental cleaning compositionsis that they cause damage the cells of the gums of the oral cavity byreactive oxygen species. An important example of such damage is lipidperoxidation which involves the oxidative degradation of unsaturatedlipids. Lipid peroxidation is highly detrimental to membrane structureand function and can cause numerous cytopathological effects. Cellsdefend against lipid peroxidation by producing radical scavengers suchas superoxide dismutase, catalase, and peroxidase. Injured cells have adecreased ability to produce radical scavengers. Excess hydrogenperoxide can react with DNA to cause backbone breakage, producemutations, and alter and liberate bases. Hydrogen peroxide can alsoreact with pyrimidines to open the 5,6-double bond. This reactioninhibits the ability of pyrimidines to hydrogen bond to complementarybases, Hallaender et al. (1971). Such oxidative biochemical injury canresult in the loss of cellular membrane integrity, reduced enzymeactivity, changes in transport kinetics, changes in membrane lipidcontent, and leakage of potassium ions, amino acids, and other cellularmaterial. In addition, the production of reactive oxygen intermediateshas been suggested to cause many tissue disorders, such as cytotoxicity,skin inflammation, gum shrinkage, etc.

A need exists for improved dental cleaning compositions that are notonly effective in whitening the teeth, but also do not cause damage tothe gums, and help remove calculus and tartar without damaging theenamel.

DETAILED DESCRIPTION Definitions

All numerical values within the detailed description and the claimsherein are modified by “about” or “approximately” the indicated value,and take into account experimental error and variations that would beexpected by a person having ordinary skill in the art.

All documents cited are, in relevant part, incorporated herein byreference; the citation of any document is not to be construed as anadmission that it is prior art with respect to the present disclosure.All percentages and ratios used herein are by weight of the specificdental cleaning composition and not of the overall dental whiteningformulation that is delivered, unless otherwise specified. Allmeasurements are made at 25° C., unless otherwise specified.

The term “comprising” means that other steps and other ingredients whichdo not affect the end result can be added.

By “dental cleaning composition” is meant a product which in theordinary course of usage, is not intentionally swallowed for purposes ofsystemic administration of particular therapeutic agents, but is ratherretained in the oral cavity for a time sufficient to contactsubstantially all of the dental surfaces and/or oral tissues forpurposes of oral activity and the cleaning, stain removal and whiteningof teeth within the oral cavity. The dental cleaning composition of thepresent disclosure may be in the form of a toothpaste, dentifrice, toothpowder, topical oral gel, mouth rinse, denture product, mouth spray,lozenge, oral tablet, chewing gum, dental floss, or combinationsthereof.

The term “dentifrice”, as used herein, means paste, gel, or liquidformulations unless otherwise specified. The dentifrice composition maybe a single phase composition or may be a combination of two or moredentifrice compositions. The dentifrice composition may be in anydesired form, such as deep striped, surface striped, multilayered,having the gel surrounding the paste, or any combination thereof. Eachdentifrice composition in a dentifrice comprising two or more separatedentifrice compositions may be contained in a physically separatedcompartment of a dispenser and dispensed side-by-side.

The term “dispenser”, as used herein, means any pump, tube, or containersuitable for dispensing toothpaste or dental floss.

The term “teeth”, as used herein, refers to natural teeth as well asartificial teeth or dental prosthesis.

The term “orally acceptable carrier” as used herein means any safe andeffective materials for use in the compositions of the presentdisclosure. Such materials include fluoride ion sources, additionalanticalculus agents, buffers, abrasive polishing materials, peroxidesources, alkali metal bicarbonate salts, thickening materials,humectants, water, surfactants, titanium dioxide, flavor system,sweetening agents, xylitol, coloring agents, and mixtures thereof.

Pellicle is the protein film that forms on the surface of the enamel byselective binding of glycol proteins.

Herein, the terms “tartar” and “calculus” are used interchangeably andrefer to mineralized dental plaque deposits.

The term “minimal gum damage” as used herein means that the gums of theoral cavity are not significantly irritated or otherwise significantlyweakened by the application of the dental cleaning compositions of thepresent disclosure.

The term “minimal enamel damage” as used herein means that the enamelsurface of the teeth in the oral cavity is not significantly damage orotherwise significantly weakened by the application of the dentalcleaning compositions of the present disclosure.

The term “substantially stoichiometric” as used herein means that theratio of the one or more oxidizing agents to the one or more reducingagents in the dental cleaning compositions is such that quantity ofreducing agents is sufficient to react with and neutralize substantiallyall of the oxidizing agents present in the composition in a subject oralcavity. However, “substantially stoichiometric” also means there may bean excess of reducing agents relative to oxidizing agents in thecompositions, that is 1 wt. % or more, or 2 wt. % or more, or 5 wt. % ormore, or 7 wt. % or more, or 10 wt. % or more of excessive reducingagent to oxidizing agent that would also be sufficient to neutralizesubstantially all of the oxidizing agents present in the composition ina subject oral cavity.

Overall Description:

The present invention relates to dental cleaning compositions used toclean teeth in the oral cavity of a human or animal, methods of makingsuch compositions and methods of using such compositions.

The dental cleaning compositions disclosed herein, which are used toclean, remove stains and whiten teeth via an oxidative type mechanism,may be in the form of a two component composition. One component carriesone or more oxidizing agents (such as hydrogen peroxide), and thecomponent carries one or more reducing agents (antioxidants).

Prior art compositions used to clean and whiten the teeth have variousdisadvantages, including, but not limited to gum damage and enameldamage due to the oxidative nature of the process. Therefore it is anobject of the present invention to overcome some or all of theaforementioned disadvantages, and in particular to provide dentalcleaning compositions which are gentler and milder to the teeth, gumsand oral cavity.

According to the present disclosure, there is provided a dental cleaningcomposition containing at least one oxidative cleaning (also referred toas an oxidizing agent) and at least one reducing agent (also referred toas an antioxidant).

In the process of cleaning and whitening teeth, it is required tooxidize the surface of the teeth. Hydrogen peroxide is an example ofsuch an oxidant, and is used to initiate the oxidation. Also susceptibleto oxidation are the gums and teeth enamel of the oral cavity. Oxidationof the gums may lead to a reduction in gum strength, and hence damage.The oxidation of the teeth and gums can follow a chain reactionmechanism, by which hydrogen peroxide is the initiator. The hydrogenperoxide molecules degenerate into reactive oxygen species, which arefree radicals, and rapidly start the chain reactions mentionedpreviously.

The applicant has discovered that one way of preventing the oxidativedamage to the gums and enamel would be to use free radical scavengingagents, e.g. reducing agents or antioxidants, to mop up the reactiveoxygen species, preventing the chain reactions. A disadvantage would bethat the free radical scavengers may also mop up the reactive oxidativeintermediate once they had been oxidized, and this would prevent furtherwhitening and cleaning of the teeth.

To overcome this problem, the present disclosure is used. The presentdisclosure relates to the use of reducing agents and more particularlyantioxidants that may be referred to as “chain-breaking”, since they arebelieved to block the chain reactions mentioned above from developingfar enough to damage the gums and the enamel of the teeth, but do notinhibit the cleaning, stain removal and whitening of the teeth bymopping up the reactive radical oxidizing agent molecules afteroxidation. Incorporation into the dental cleaning formulation of the“chain-breaking” reducing agents/antioxidants has been shown to reduceconsiderably and significantly the level of gum and enamel damage.

The dental cleaning composition according to the present disclosure maycontain a single one of the chain-breaking reducing agents/antioxidants.However, the reducing agents/antioxidants have shown significantsynergistic action in combination with each other, enhancing theprotection of the gums and enamel of the teeth against oxidative damage.This action is shown to be present with no adverse effect on thecleaning, stain removal and whitening of the teeth.

Various Aspects of the Disclosed Embodiment

The present disclosure provides novel dental cleaning compositions,methods of making such compositions and methods of applying suchcompositions to the teeth. The compositions are distinguishable over theprior art in providing a combination of an oxidizing agent(s) and areducing agent(s) in one or more orally acceptable carriers, which areeither co-dispensed or sequentially dispensed and minimize gum damageassociated with conventional dental cleaning compositions.

In one exemplary aspect of the present disclosure, the dental cleaningcomposition includes a substantially stoichiometric ratio of one or moreoxidizing agents to one or more reducing agents in one or more orallyacceptable carriers, wherein the oxidizing agent and reducing agent ofthe dental composition are either co-dispensed or sequentiallydispensed.

In another exemplary aspect of the present disclosure, the dentalcleaning composition includes 0.5 to 90 wt. % of one or more reducingagents in one or more orally acceptable carriers, wherein the one ormore reducing agents are chosen from good grade antioxidants.

In an alternative aspect of the present disclosure, the method forwhitening teeth includes: providing a dental cleaning compositionincluding a substantially stoichiometric ratio of one or more oxidizingagents to one or more reducing agents in one or more orally acceptablecarriers, and applying the dental cleaning composition to the oralcavity in a form chosen from a toothpaste, dentifrice, tooth powder,topical oral gel, mouth rinse, denture product, mouth spray, lozenge,oral tablet, or chewing gum, impregnated dental implement, andcombinations thereof, wherein the oxidizing agent and reducing agent ofthe dental composition are either co-dispensed or sequentiallydispensed.

In another exemplary aspect of the present disclosure, a method ofmaking the dental cleaning composition includes providing asubstantially stoichiometric ratio of one or more oxidizing agents, oneor more reducing agents, and one or more orally acceptable carriers,mixing the one or more oxidizing agents into one or more orallyacceptable carriers, mixing the one or more reducing agents into one ormore orally acceptable carriers, and combining the mixture of the one ormore oxidizing agents in one or more orally acceptable carriers and themixture of the one or more reducing agents in one or more orallyacceptable carriers in a form for either co-dispensing or sequentiallydispensing, and wherein the form for either co-dispensing orsequentially dispensing the dental cleaning composition to an oralcavity is chosen from a toothpaste, dentifrice, tooth powder, topicaloral gel, mouth rinse, denture product, mouth spray, lozenge, oraltablet, chewing gum, impregnated dental implement, and combinationsthereof.

Oxidizing Agents:

The oxidizing agent functions primarily to whiten the teeth and is alsocommonly referred to as a teeth whitening actives. The oxidizing agentssuitable for the dental cleaning compositions of the present disclosureinclude peroxides, metal chlorites, perborates, percarbonates,peroxyacids, persulfates, and combinations thereof. Suitable peroxidecompounds include hydrogen peroxide, urea peroxide, calcium peroxide,and mixtures thereof. Suitable metal chlorites include calcium chlorite,barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite,and potassium chlorite. The preferred chlorite is sodium chlorite.Additional oxidizing agents may be hypochlorite and chlorine dioxide. Apreferred percarbonate is sodium percarbonate. Other suitable oxidizingagents include potassium, ammonium, sodium and lithium persulfates andperborate mono- and tetrahydrates, and sodium pyrophosphateperoxyhydrate. In addition, a combination of the one or more oxidizingagents as described above may be used in the dental cleaning compositiondisclosed herein.

Dental bleaching compositions including peroxide bleaching (oxidizing)agents are further described in U.S. Pat. No. 6,908,607, hereinincorporated by reference in its entirety.

Reducing Agents:

The reducing agent of the present disclosure is an element or compoundin a reduction-oxidation reaction that donates an electron to the one ormore oxidizing agents. The one or more reducing agents functionprimarily to neutralize and/or terminate the oxidizing agent(s) andtherefore to help minimize gum damage. The reducing agent may be watersoluble or non-water (oil) soluble. Non-limiting exemplary reducingagents suitable for neutralizing the one or more oxidizing agents of thepresent disclosure include lithium aluminium hydride (LiAlH₄), nascenthydrogen, sodium amalgam, sodium borohydride (NaBH₄), compoundscontaining the Sn²⁺ ion, such as tin(II) chloride, compounds containingbismuth ions (bismuth compounds), sulfite compounds, hydrazine(Wolff-Kishner reduction), diisobutylaluminum hydride (DIBAH), Lindlarcatalyst, ascorbic acid and ascorbyl glycoside (Vitamin C), phosphites,hypophosphites and phosphorous acid, dithiothreitol (DTT), and compoundscontaining the Fe²⁺ ion, such as iron(II) sulfate, and combinationsthereof.

Other suitable reducing agents include antioxidants. Antioxidants aremolecules capable of inhibiting the oxidation of other molecules.Oxidation is a chemical reaction that transfers electrons from asubstance to an oxidizing agent. Oxidation reactions can produce freeradicals. In turn, these radicals can start chain reactions that damagecells and in particular the gums of the oral cavity when used aswhitening agents. Antioxidants terminate these chain reactions byremoving free radical intermediates, and inhibit other oxidationreactions, which may damage the gums of the oral cavity. Antioxidantsfunction by being oxidized themselves, so antioxidants are oftenreducing agents. Antioxidants are classified into two broad divisions,depending on whether they are soluble in water (hydrophilic) or inlipids (hydrophobic). For food grade antioxidants, the oxygen radicalabsorbance capacity (ORAC) in vitro provides an artificial index ofantioxidant strength. Vitamins A, C and E have antioxidant efficacy invivo. A food “rich in antioxidants” typically means at least a ORACrating of 1000 per 100 g.

Non-limiting exemplary antioxidants suitable for the one or morereducing agents of the present disclosure are as follows: selenium,zinc, ascorbic acid (Vitamin C), polyphenols (gallic acid, pyrogallol,quercetin, ethyl gallate, naringenin, luteolin, hesperidin, catechins),uric acid, lipoic acid, melatonin, glutathione, polyphenols,α-tocopherols and tocotrienols (Vitamin E), thiols, Vitamin A,carotenes, Vitamin D, ubiquinol (coenzyme Q), propyl gallate (PG, E310),tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole (BHA, E320),butylated hydroxytoluene (BHT, E321), and combinations thereof.

Non-limiting exemplary catechins include epigallocatechin-3-O-gallate(EGCG), epicatechin-3-O-gallate (ECG), epigallocatechin (EGC),epicatechin (EC), epigallocatechin-3-O-(3-O-methyl)gallate (EGC3″Me),epigallocatechin-3-O-(4-O-methyl)gallate (EGC4″Me), 4′-O-Methylepigallocatechin-3-O-gallate (EGCG4′Me), 4′-O-Methylepigallocatechin-3-O-(4-O-methyl)gallate (EGCG4′,4″diMe),epigallocatechin-3-O-(3,4-O-dimethyl)gallate (EGCG3″,4″diMe),epicatechin-3-O-(3-O-methyl)gallate (ECG3″Me),epicatechin-3-O-(4-O-methyl)gallate (ECG4″Me), 4′-O-Methylepicatechin-3-O-gallate (ECG4′Me), 3′-O-Methylepicatechin-3-O-(4-O-methyl)gallate(ECG3′4″diMe), 4′-O-Methylepicatechin-3-O-(4-O-methyl)gallate (ECG4′4″diMe),epicatechin-3-O-(3,4-O-dimethyl)gallate (ECG3″,4″diMe), gallocatechin(GC), catechin (C), gallocatechin-3-O-(3-O-methyl)gallate(GCG3″Me), andgallocatechin-3-O-(4-O-methyl)gallate(GCG4″Me).

Other exemplary antioxidants suitable with the dental cleansingcomposition disclosed herein include rosmarinic acid, cynarin, cyanidin3-O-β-glucopyranoside, echinacoside, puerarin, and oleuropein.

One preferred form of Vitamin C for use in the composition is asascorbic acid or the equivalent of a salt of ascorbic acid or theequivalent of a derivative of ascorbic acid. The vitamin C may either bein an immediate release form or a sustained release form.

Vitamin A (retinol) and carotene can be obtained from either animal orvegetable sources. The vitamin A can be in the form of vitamin A,retinol, retinyl palmitate, retinyl acetate, retinyl propriante,beta-carotene, alpha carotene, beta-cryptoxanthin, and mixtures thereof.

Nonlimiting examples of Vitamin D suitable for the present disclosureinclude Vitamin D3 (cholecalciferol), Vitamin D2 (ergocalciferol) andcombinations thereof. Additional, nonlimiting examples also includemetabolites of Vitamin D, including calcidiol, calcitriol, andcombinations thereof. The Vitamin D, including cholecalciferol,ergocalciferol, calcidiol and calcitriol, may be derived from syntheticor natural sources. Vitamin D, including cholecalciferol and calcitriol,may be sourced from an extract of solanum glaucophyllum (malacoxylon),trisetum flavescens (goldhafer) or cestrum diurnum. Both the pure,Vitamin D and/or glycosides of the Vitamin D may be used.

In another form of the present disclosure, natural antioxidants may beused, including, but not limited to the following: lemon peel powder,grapefruit peel powder, melon peel powder, honeydew peel powder,pomegranate peel powder, papaya peel powder, or any other fruit with asufficiently hard peel such that it can be processed into an abrasivepowder. The abrasive powder preferably has a Mohs scale hardness ratingof 1.5 to 5.0, or 2.0 to 4.5, or more advantageously less than 2.5 inorder to avoid gum damage. Dried fruits are also a goods source ofantioxidants and include, but are not limited to, raisins, figs, dates,blueberry, cranberry, blackberry, prune, raspberry, strawberry, apple,pecan, cherry, plum, pear, guava, mango, grapes, blackcurrant, orange,peach, cantaloupe, apricots, and kiwi. Good grade (Generally recognizedas safe (GRAS) grades) antioxidants are preferable. These naturalantioxidants derived from fruits may be produced by a freeze dryingprocess to form concentrated extracts. These natural antioxidants mayalso function as abrasive and/or cleaning agents, and in particular,when formed from a fruit with a sufficiently hard peel. Theseantioxidants have the functional capacity to remove calculas and plaqueaccording to the American Dental Association (ADA) accepted testmethods.

The natural antioxidants suitable for use with the dental cleaningcomposition disclosed herein may be vegetable based, and include, butnot limited to the following: beet, red pepper, eggplant, brusselssprout, broccoli, cabbage, mushroom, asparagus, green pepper,cauliflower, spinach, carrot, chili pepper, sweet potato, radish, yellowonion, lettuce, potato, sweet corn, white onion, squash, celery,zucchini, romaine lettuce, green pea, beetroot, avocado, green, bean,cucumber, broccoli rape, corn, garlic, kale, iceberg lettuce, leaflettuce, broccoli flowers, artichoke, alfalfa sprouts, cherry-tomato,chive, red bean, kidney bean, black bean, pinto bean, russet potato, andasparagus. These vegetables may be produced by a freeze drying processto form concentrated extracts for use in the dental cleaning compositiondisclosed herein.

Other natural antioxidants suitable for use with the dental cleaningcomposition disclosed herein may also include herbal botanical extracts,such as green tea and black tea extracts.

Other vitamin cofactors and minerals suitable for antioxidants includecoenzyme manganese, selenium, tin, bismuth, and manganese. Hormonessuitable for antioxidants includes melatonin, Carotenoid terpenoidssuitable for antioxidants include alpha-carotene, astaxanthin,beta-carotene, canthaxanthin, lutein, lycopene, and zeaxanthin.Flavonoid polyphenolics suitable for antixoxidants include flavones(apigenin, luteolin, tangeritin), flavonols (isorhamnetin, kaempferol,myricetin, proanthocyanidins, condensed tannins, quercetin, rutin),flavanones (eriodictyol, hesperetin, naringenin), flavanols and theirpolymers (catechin, gallocatechin and corresponding gallate esters,epicatechin, epigallochtechin and corresponding gallate esters,theaflavin and its gallate esters, thearubigins), isoflavonephytoestrogens (daidzein, genistein, glycitein), stilbenoids(reservatrol, pterostilibene) and anthocyanins (cyanidin, delphinidin,malvidin, pelargonidin, peonidin, petunidin). Phenolic acids and theiresters suitable for antioxidants include chicoric acid, chlorogenicacid, cinnamic acid and its derivatives, such as ferulic acid, ellagicacid, ellagitannins, gallic acid, gallotannins, rosmarinic acid, andsalicyclic acid. Other nonflavonoid phenolics suitable as antioxidantsinclude curcumin, flavonolignans, xanthones and eugenol. Other potentialorganic antioxidants include bilurubin, citric acid, oxalic acid, phyticacid, n-acetylcysteine (water soluble), R-α-lipoic acid (fat and watersoluble) and uric acid.

A good source of polyphenol antioxidants are nuts, including, but notlimited to, pecans, walnuts, hazelnuts, pistachio, almond, cashew nut,macadamia nut and peanuts.

Spices may also be used as antioxidants including, but not limited to,clove, cinnamon, oregano, turmeric, cumin, parsley, basil, curry powder,mustard seed, ginger, pepper, chili powder, paprika, garlic, coriander,onion and cardamom.

Herbs may also be used as antioxidants including, but not limited to,sage, thyme, marjoram, tarragon, peppermint, oregano, savory, basil anddill weed.

Co-Dispensing and Sequential Dispensing of Dental Cleaning Composition:

The dental cleaning composition of the present disclosure may be in theform of a dentifrice, toothpaste, tooth powder, topical oral gel, mouthrinse, denture product, mouth spray, lozenge, oral tablet, chewing gum,dental floss, or combinations thereof.

The dental cleaning compositions of the present disclosure may have a pHranging from 4 to 10, or 4 to 9, or 6 to 9, or 4 to 8, or 6 to 8, or 7to 8.

The one or more oxidizing agents and one or more reducing agents may beco-dispensed or sequentially dispensed. In a co-dispensed system, theoxidizing agent(s) and reducing agent(s) may be in a single phase. Inone form of the co-dispensed system, the oxidizing agent(s) will bewater soluble and the reducing agent(s) will be water insoluble andincluded within a single-phase. In a single-phase system, the reducingagent(s) and/or oxidizing agent(s) may be encapsulated in a material toprovide physical separation of the two agents. The encapsulation may bebroken via a mechanical means (i.e. brushing, gargling or otheragitation of the oral cavity) to provide for the reducing agent(s) toneutralize the oxidizing agent(s). Non-limiting examples ofencapsulating agents include gums, starches, polymers and otherhydrophobic materials.

One non-limiting exemplary form of a co-dispensed system is when theoxidizing and reducing agents are in the form of toothpaste or a mouthrinse. Where the oxidizing agents and reducing agents are such that oneis water soluble and the other is water insoluble, a single phaseco-dispensed method of application is preferred.

In a sequentially dispensed system, the oxidizing agent(s) and itsorally acceptable carrier(s) will be physically separated from thereducing agent(s) and its orally acceptable carrier(s) (two or morephase system). For example, a two or more cavity toothpaste tube,wherein the oxidizing agent(s)/orally acceptable carrier(s) arephysically separated from reducing agent(s)/orally acceptable carrier(s)is one form of a sequentially dispensed system. In this system, theoxidizing agent(s)/orally acceptable carrier(s) and reducingagent(s)/orally acceptable carrier(s) are combined when the toothpasteenters the oral cavity. The oxidizing agent(s) provide the whitening andcleaning to the teeth and the reducing agent(s) neutralize/terminate theoxidization reaction to minimize gum damage. In another form of asequential system, a tooth paste may include the oxidizingagent(s)/orally acceptable carrier(s), which is first applied to theoral cavity. This is followed by the application of a mouth rinseincluding reducing agent(s)/orally acceptable carrier(s) toneutralize/terminate the residual oxidizing agents from the toothpaste.With a sequential system, the oxidizing agent(s) and reducing agents(s)are generally not in a single phase. Hence, a water soluble oxidizingagent and a water soluble reducing agent may be used. Where both theoxidizing and reducing agents are water soluble, a two-phase sequentialmethod of application is preferred.

The oxidizing agent(s) may be co-dispensed or sequentially dispensed inthe form of a dental floss dispensed through a two-chamber dispenser.U.S. Pat. No. 6,705,328 discloses methods of impregnating and dispensingdental floss using novel dental floss dispensers and is incorporated byreference in its entirety herein.

In addition to the oxidizing agents and reducing agents described above,the present compositions may comprise additional components, which aredescribed in the following paragraphs.

Orally Acceptable Carrier:

The orally acceptable carrier comprises one or more compatible solid orliquid filler diluents or encapsulating substances which are suitablefor topical oral administration. By “compatible,” as used herein, ismeant that the components of the composition are capable of beingcommingled without interaction in a manner which would substantiallyreduce the composition's stability and/or efficacy.

The carriers or excipients of the present disclosure can include theusual and conventional components of dentifrices (including non-abrasivegels and gels for subgingival application), mouth rinses, mouth sprays,chewing gums, and lozenges (including breath mints) as more fullydescribed hereinafter.

The choice of a carrier to be used is basically determined by the waythe composition is to be introduced into the oral cavity. If atoothpaste (including tooth gels, etc.) is to be used, then a“toothpaste carrier” is chosen (e.g., abrasive materials, sudsingagents, binders, humectants, flavoring and sweetening agents, etc.) asdisclosed in, e.g., U.S. Pat. No. 3,988,433, to Benedict. If a mouthrinse is to be used, then a “mouth rinse carrier” is chosen (e.g.,water, flavoring and sweetening agents, etc.), as disclosed in, e.g.,U.S. Pat. No. 3,988,433 to Benedict. Similarly, if a mouth spray is tobe used, then a “mouth spray carrier” is chosen or if a lozenge is to beused, then a “lozenge carrier” is chosen (e.g., a candy base), candybases being disclosed in, e.g., U.S. Pat. No. 4,083,955, toGrabenstetter et al.; if a chewing gum is to be used, then a “chewinggum carrier” is chosen (e.g., gum base, flavoring and sweeteningagents), as disclosed in, e.g., U.S. Pat. No. 4,083,955, toGrabenstetter et al. If a sachet is to be used, then a “sachet carrier”is chosen (e.g., sachet bag, flavoring and sweetening agents). If asubgingival gel is to be used (for delivery of actives into theperiodontal pockets or around the periodontal pockets), then a“subgingival gel carrier” is chosen as disclosed in, e.g. U.S. Pat. Nos.5,198,220 and 5,242,910, issued Mar. 30, 1993 and Sep. 7, 1993,respectively both to Damani. Carriers suitable for the preparation ofcompositions of the present disclosure are well known in the art. Theirselection will depend on secondary considerations like taste, cost, andshelf stability, etc.

The compositions of the present disclosure may be in the form ofnon-abrasive gels, including subgingival gels, which may be aqueous ornon-aqueous. Aqueous gels generally include a thickening agent (fromabout 0.1% to about 20%), a humectant (from about 10% to about 55%), aflavoring agent (from about 0.04% to about 2%), a sweetening agent (fromabout 0.1% to about 3%), a coloring agent (from about 0.01% to about0.5%), and the balance water. The compositions may comprise ananticaries agent (from about 0.05% to about 0.3% as fluoride ion), andan anticalculus agent (from about 0.1% to about 13%).

Preferred compositions of the present disclosure may also be in the formof dentifrices, such as toothpastes, tooth gels and tooth powders.Components of such toothpaste and tooth gels generally include one ormore of a dental abrasive (from about 6% to about 50%), a surfactant(from about 0.5% to about 10%), a thickening agent (from about 0.1% toabout 5%), a humectant (from about 10% to about 55%), a flavoring agent(from about 0.04% to about 2%), a sweetening agent (from about 0.1% toabout 3%), a coloring agent (from about 0.01% to about 0.5%) and water(from about 2% to about 45%). Such toothpaste or tooth gel may alsoinclude one or more of an anticaries agent (from about 0.05% to about0.3% as fluoride ion), and an anticalculus agent (from about 0.1% toabout 13%). Tooth powders, of course, contain substantially allnon-liquid components.

Other preferred compositions of the present disclosure are mouthwashes,including mouth sprays. Components of such mouthwashes and mouth spraystypically include one or more of water (from about 45% to about 95%),ethanol (from about 0% to about 25%), a humectant (from about 0% toabout 50%), a surfactant (from about 0.01% to about 7%), a flavoringagent (from about 0.04% to about 2%), a sweetening agent (from about0.1% to about 3%), and a coloring agent (from about 0.001% to about0.5%). Such mouthwashes and mouth sprays may also include one or more ofan anticaries agent (from about 0.05% to about 0.3% as fluoride ion),and an anticalculus agent (from about 0.1% to about 3%).

Other preferred compositions of the present disclosure are dentalsolutions including irrigation fluids. Components of such dentalsolutions generally include one or more of water (from about 90% toabout 99%), preservative (from about 0.01% to about 0.5%), thickeningagent (from 0% to about 5%), flavoring agent (from about 0.04% to about2%), sweetening agent (from about 0.1% to about 3%), and surfactant(from 0% to about 5%).

Chewing gum compositions typically include one or more of a gum base(from about 50% to about 99%), a flavoring agent (from about 0.4% toabout 2%) and a sweetening agent (from about 0.01% to about 20%).

The term “lozenge” as used herein includes: breath mints, troches,pastilles, microcapsules, and fast-dissolving solid forms includingfreeze dried forms (cakes, wafers, thin films, tablets) andfast-dissolving solid forms including compressed tablets. The term“fast-dissolving solid form” as used herein means that the solid dosageform dissolves in less than about 60 seconds, preferably less than about15 seconds, more preferably less than about 5 seconds, after placing thesolid dosage form in the oral cavity. Fast-dissolving solid forms aredisclosed in U.S. patent application Ser. No. 08/253,890, filed Jun. 3,1994, Brideau; U.S. Pat. Nos. 4,642,903; 4,946, 684; 4,305,502;4,371,516; 5,188,825; 5,215,756; 5,298,261; 3,882, 228; 4,687, 662;4,642,903.

Lozenges include discoid-shaped solids comprising a therapeutic agent ina flavored base. The base may be a hard sugar candy, glycerinatedgelatin or combination of sugar with sufficient mucilage to give itform. These dosage forms are generally described in Remington: TheScience and Practice of Pharmacy, 19^(th) Ed., Vol. 11, Chapter 92,1995. Lozenge compositions (compressed tablet type) typically includeone or more fillers (compressible sugar), flavoring agents, andlubricants. Microcapsules of the type contemplated herein are disclosedin U.S. Pat. No. 5,370,864, Peterson et al., issued Dec. 6, 1994.

In still another aspect, the disclosure comprises a dental implementimpregnated with the present composition. The dental implement comprisesan implement for contact with teeth and other tissues in the oralcavity, said implement being impregnated with a composition comprisingthe present oxidizing agent and reducing agent. The dental implement canbe impregnated fibers including dental floss or tape, chips or stripsand polymer fibers.

Types of carriers or oral care excipients which may be included incompositions of the present disclosure, along with specific non-limitingexamples, are discussed in the following paragraphs.

Abrasives:

Dental abrasives, like the dental polishing agents, also cause a smallamount of enamel erosion which is termed “polishing” action. The removalof plaque and calculus prevents caries and periodontal disease. Thepolishing of teeth removes stains from tooth surfaces, but has not beenshown to improve dental health over and above the effects of the removalof plaque and calculus. Dental abrasives have a Mohs hardness rangingfrom 1.5 to 5.0, or 2.5 to 5.0, or 3.0 to 4.5, or 3.5 to 4.0. Typicaldental abrasives are carbonates and pyrophosphates. Preferably,antioxidants that function as also abrasives should be used in thedental compositions disclosed herein. These antioxidants have thecapacity to neutralize oxidizing agents in the subject oral cavity,clean the teeth and also abrade/polish the teeth.

Antioxidants that are also useful as abrasives are those discussed abovein polymeric peel form. The peel of the fruit may be freeze dried andthen reacted with carbonate to form polylimine carbonate. Polymericcuteins of suitable peels are usually polyester polymers, likepolylimones (artificial plastics from polylimone carbonate polymer) fromthe rind or peel/skin of the fruit (such as from oranges and corn). Thecutein from fruits are typically polyesters of omega hydroxy acids anduseful as abrasives if they have a Mohs hardness of less than or equalto 2.5 and preferably 1.5 to 2.5. Suberin is a waxy substance found inhigher plants and is a main constituent of cork, such as cork oak.Suberins are divided into polyaromatic/polyaliphatic natural polymers,and may be used as abrasives that also function as antioxidants.

Dental abrasives useful in the topical, oral carriers of thecompositions of the subject disclosure include many different materials.The material selected must be one which is compatible within thecomposition of interest and does not excessively abrade dentin. Suitableabrasives include, for example, silicas including gels and precipitates,insoluble sodium polymetaphosphate, hydrated alumina, calcium carbonate,dicalcium orthophosphate dihydrate, calcium pyrophosphate, tricalciumphosphate, calcium polymetaphosphate, and resinous abrasive materialssuch as particulate condensation products of urea and formaldehyde.

Another class of abrasives for use in the present compositions is theparticulate thermo-setting polymerized resins as described in U.S. Pat.No. 3,070,510 issued to Cooley & Grabenstetter on Dec. 25, 1962.Suitable resins include, for example, melamines, phenolics, ureas,melamine-ureas, melamine-formaldehydes, urea-formaldehyde,melamine-urea-formaldehydes, cross-linked epoxides, and cross-linkedpolyesters.

Silica dental abrasives of various types are preferred because of theirunique benefits of exceptional dental cleaning and polishing performancewithout unduly abrading tooth enamel or dentine. The silica abrasivepolishing materials herein, as well as other abrasives, generally havean average particle size ranging between about 0.1 to about 30 microns,and preferably from about 5 to about 15 microns. The abrasive can beprecipitated silica or silica gels such as the silica xerogels describedin Pader et al., U.S. Pat. No. 3,538,230, issued Mar. 2, 1970, andDiGiulio, U.S. Pat. No. 3,862,307, issued Jan. 21, 1975. Preferred arethe silica xerogels marketed under the trade name “Syloid” by the W. R.Grace & Company, Davison Chemical Division. Also preferred are theprecipitated silica materials such as those marketed by the J. M. HuberCorporation under the trade name, Zeodent®, particularly the silicascarrying the designation Zeodent® 119, Zeodent® 118, Zeodent® 109 andZeodent® 129. The types of silica dental abrasives useful in thetoothpastes of the present disclosure are described in more detail inWason, U.S. Pat. No. 4,340,583, issued Jul. 29, 1982; and incommonly-assigned U.S. Pat. No. 5,603,920, issued on Feb. 18, 1997; U.S.Pat. No. 5,589,160, issued Dec. 31, 1996; U.S. Pat. No. 5,658,553,issued Aug. 19, 1997; U.S. Pat. No. 5,651,958, issued on Jul. 29, 1997,and U.S. Provisional Application Ser. No. 60/300,766, filed Jun. 25,2001.

Mixtures of abrasives can be used such as mixtures of the various gradesof silica with one or more fruit antioxidant abrasives listed above. Thetotal amount of abrasive in dentifrice compositions of the presentdisclosure preferably range from about 6% to about 70% by weight;toothpastes preferably contain from about 10% to about 50% of abrasives,by weight of the composition. Solution, mouth spray, mouthwash andnon-abrasive gel compositions of the present disclosure typicallycontain no abrasive.

Surfactants:

The present compositions may also comprise surfactants, also commonlyreferred to as sudsing agents. Suitable surfactants are those which arereasonably stable and foam throughout a wide pH range. The surfactantmay be anionic, nonionic, amphoteric, zwitterionic, cationic, ormixtures thereof.

Anionic surfactants useful herein include the water-soluble salts ofalkyl sulfates having from 8 to 20 carbon atoms in the alkyl radical(e.g., sodium alkyl sulfate) and the water-soluble salts of sulfonatedmonoglycerides of fatty acids having from 8 to 20 carbon atoms. Sodiumlauryl sulfate and sodium coconut monoglyceride sulfonates are examplesof anionic surfactants of this type. Other suitable anionic surfactantsare sarcosinates, such as sodium lauroyl sarcosinate, taurates, sodiumlauryl sulfoacetate, sodium lauroyl isethionate, sodium laurethcarboxylate, and sodium dodecyl benzenesulfonate. Mixtures of anionicsurfactants can also be employed. Many suitable anionic surfactants aredisclosed by Agricola et al., U.S. Pat. No. 3,959,458, issued May 25,1976. The present composition typically comprises an anionic surfactantat a level of from about 0.025% to about 9%, preferably from about 0.05%to about 5%, and most preferably from about 0.1% to about 1%.

Another preferred surfactant is one selected from the group consistingof sarcosinate surfactants, isethionate surfactants and tauratesurfactants. Preferred for use herein are alkali metal or ammonium saltsof these surfactants. Most preferred herein are the sodium and potassiumsalts of the following: lauroyl sarcosinate, myristoyl sarcosinate,palmitoyl sarcosinate, stearoyl sarcosinate and oleoyl sarcosinate. Thissurfactant can be present in the compositions of the present disclosurefrom about 0.1% to about 2.5%, preferably from about 0.3% to about 2.5%and most preferably from about 0.5% to about 2.0% by weight of the totalcomposition.

Preferred cationic surfactants useful in the present disclosure can bebroadly defined as derivatives of aliphatic quaternary ammoniumcompounds having one long alkyl chain containing from about 8 to 18carbon atoms such as lauryl trimethylammonium chloride; cetyl pyridiniumchloride; cetyl trimethylammonium bromide;di-isobutylphenoxyethyl-dimethylbenzylammonium chloride; coconutalkyltrimethylammonium nitrite; cetyl pyridinium fluoride; etc.Preferred compounds are the quaternary ammonium fluorides described inU.S. Pat. No. 3,535,421, Oct. 20, 1970, to Briner et al., where saidquaternary ammonium fluorides have detergent properties. Certaincationic surfactants can also act as germicides in the compositionsdisclosed herein. Cationic surfactants such as chlorhexidine, althoughsuitable for use in the current disclosure, are not preferred due totheir capacity to stain the oral cavity's hard tissues. Persons skilledin the art are aware of this possibility and should incorporate cationicsurfactants only with this limitation in mind.

Preferred nonionic surfactants that can be used in the compositions ofthe present disclosure can be broadly defined as compounds produced bythe condensation of alkylene oxide groups (hydrophilic in nature) withan organic hydrophobic compound which may be aliphatic or alkylaromaticin nature. Examples of suitable nonionic surfactants include thepluronics, polyethylene oxide condensates of alkyl phenols, productsderived from the condensation of ethylene oxide with the reactionproduct of propylene oxide and ethylene diamine, ethylene oxidecondensates of aliphatic alcohols, long chain tertiary amine oxides,long chain tertiary phosphine oxides, long chain dialkyl sulfoxides andmixtures of such materials.

Preferred zwitterionic synthetic surfactants useful in the presentdisclosure can be broadly described as derivatives of aliphaticquaternary ammonium, phosphonium, and sulfonium compounds, in which thealiphatic radicals can be straight chain or branched, and wherein one ofthe aliphatic substituents contains from about 8 to 18 carbon atoms andone contains an anionic water-solubilizing group, e.g., carboxy,sulfonate, sulfate, phosphate or phosphonate.

Preferred betaine surfactants are disclosed in U.S. Pat. No. 5,180,577to Polefka et al., issued Jan. 19, 1993. Typical alkyl dimethyl betainesinclude decyl betaine or 2-(N-decyl-N,N-dimethylammonio) acetate, cocobetaine or 2-(N-coc-N, N-dimethyl ammonio) acetate, myristyl betaine,palmityl betaine, lauryl betaine, cetyl betaine, cetyl betaine, stearylbetaine, etc. The amidobetaines are exemplified by cocoamidoethylbetaine, cocoamidopropyl betaine, lauramidopropyl betaine and the like.The betaines of choice are preferably the cocoamidopropyl betaine and,more preferably, the lauramidopropyl betaine.

Anticalculus Agent:

The present compositions may also include an anticalculus agent,preferably a pyrophosphate ion source which is from a pyrophosphatesalt. The pyrophosphate salts useful in the present compositions includethe dialkali metal pyrophosphate salts, tetraalkali metal pyrophosphatesalts, and mixtures thereof. Disodium dihydrogen pyrophosphate(Na₂H₂P₂O₇), tetrasodium pyrophosphate (Na₄P₂O₇), and tetrapotassiumpyrophosphate (K₄P₂O₇) in their unhydrated as well as hydrated forms arethe preferred species. In compositions of the present disclosure, thepyrophosphate salt may be present in one of three ways: predominatelydissolved, predominately undissolved, or a mixture of dissolved andundissolved pyrophosphate.

Compositions comprising predominately dissolved pyrophosphate refer tocompositions where at least one pyrophosphate ion source is in an amountsufficient to provide at least about 1.0% free pyrophosphate ions. Theamount of free pyrophosphate ions may be from about 1% to about 15%,preferably from about 1.5% to about 10%, and most preferably from about2% to about 6%. Free pyrophosphate ions may be present in a variety ofprotonated states depending on a the pH of the composition.

Compositions comprising predominately undissolved pyrophosphate refer tocompositions containing no more than about 20% of the totalpyrophosphate salt dissolved in the composition, preferably less thanabout 10% of the total pyrophosphate dissolved in the composition.Tetrasodium pyrophosphate salt is the preferred pyrophosphate salt inthese compositions. Tetrasodium pyrophosphate may be the anhydrous saltform or the decahydrate form, or any other species stable in solid formin the dentifrice compositions. The salt is in its solid particle form,which may be its crystalline and/or amorphous state, with the particlesize of the salt preferably being small enough to be aestheticallyacceptable and readily soluble during use. The amount of pyrophosphatesalt useful in making these compositions is any tartar control effectiveamount, and is generally from about 1.5% to about 15%, preferably fromabout 2% to about 10%, and most preferably from about 3% to about 8%, byweight of the dentifrice composition.

Compositions may also comprise a mixture of dissolved and undissolvedpyrophosphate salts. Any of the above mentioned pyrophosphate salts maybe used. The pyrophosphate salts are described in more detail inKirk-Othmer Encyclopedia of Chemical Technology, Third Edition, Volume17, Wiley-Interscience Publishers (1982).

Chelating Agents:

Another preferred optional agent is a chelating agent such as tartaricacid and pharmaceutically-acceptable salts thereof, citric acid andalkali metal citrates and mixtures thereof. Chelating agents are able tocomplex calcium found in the cell walls of the bacteria. Chelatingagents can also disrupt plaque by removing calcium from the calciumbridges which help hold this biomass intact. However, it is not desiredto use a chelating agent which has an affinity for calcium that is toohigh, as this may result in tooth demineralization, which is contrary tothe objects and intentions of the present disclosure.

Sodium and potassium citrate are the preferred alkali metal citrates,with sodium citrate being the most preferred. Also preferred is a citricacid/alkali metal citrate combination. Preferred herein are alkali metalsalts of tartaric acid. Most preferred for use herein are disodiumtartrate, dipotassium tartrate, sodium potassium tartrate, sodiumhydrogen tartrate and potassium hydrogen tartrate. The amounts ofchelating agent suitable for use in the present disclosure are about0.1% to about 2.5%, preferably from about 0.5% to about 2.5% and morepreferably from about 1.0% to about 2.5%. The tartaric acid saltchelating agent can be used alone or in combination with other optionalchelating agents.

Other optional chelating agents can be used. Preferably these chelatingagents have a calcium binding constant of about 10¹ to 10⁵ provideimproved cleaning with reduced plaque and calculus formation.

Still another possible group of chelating agents suitable for use in thepresent disclosure are the anionic polymeric polycarboxylates. Suchmaterials are well known in the art, being employed in the form of theirfree acids or partially or preferably fully neutralized water solublealkali metal (e.g. potassium and preferably sodium) or ammonium salts.Preferred are 1:4 to 4:1 copolymers of maleic anhydride or acid withanother polymerizable ethylenically unsaturated monomer, preferablymethyl vinyl ether (methoxyethylene) having a molecular weight (M.W.) ofabout 30,000 to about 1,000,000. These copolymers are available forexample as Gantrez AN 139 (M.W. 500,000), AN 119 (M.W. 250,000) andpreferably S-97 Pharmaceutical Grade (M.W. 70,000), of GAF ChemicalsCorporation.

Other operative polymeric polycarboxylates include those such as the 1:1copolymers of maleic anhydride with ethyl acrylate, hydroxyethylmethacrylate, N-vinyl-2-pyrrolidone, or ethylene, the latter beingavailable for example as Monsanto EMA No. 1103, M.W. 10,000 and EMAGrade 61, and 1:1 copolymers of acrylic acid with methyl or hydroxyethylmethacrylate, methyl or ethyl acrylate, isobutyl vinyl ether orN-vinyl-2-pyrrolidone.

Additional operative polymeric polycarboxylates are disclosed in U.S.Pat. No. 4,138,477, Feb. 6, 1979 to Gaffar and U.S. Pat. No. 4,183,914,Jan. 15, 1980 to Gaffar et al. and include copolymers of maleicanhydride with styrene, isobutylene or ethyl vinyl ether; polyacrylic,polyitaconic and polymaleic acids; and sulfoacrylic oligomers of M.W. aslow as 1,000 available as Uniroyal ND-2.

Fluoride Source:

It is common to have an additional water-soluble fluoride compoundpresent in dentifrices and other oral compositions in an amountsufficient to give a fluoride ion concentration in the composition at25° C., and/or when it is used of from about 0.0025% to about 5.0% byweight, preferably from about 0.005% to about 2.0% by weight, to provideadditional anticaries effectiveness. A wide variety of fluorideion-yielding materials can be employed as sources of soluble fluoride inthe present compositions. Examples of suitable fluoride ion-yieldingmaterials are found in U.S. Pat. No. 3,535,421, Oct. 20, 1970 to Brineret al. and U.S. Pat. No. 3,678,154, Jul. 18, 1972 to Widder et al.Representative fluoride ion sources include: stannous fluoride, sodiumfluoride, potassium fluoride, sodium monofluorophosphate and manyothers. Stannous fluoride and sodium fluoride are particularlypreferred, as well as mixtures thereof.

Thickening Agents:

In preparing toothpaste or gels, it is necessary to add some thickeningmaterial to provide a desirable consistency of the composition, toprovide desirable active release characteristics upon use, to provideshelf stability, and to provide stability of the composition, etc.Preferred thickening agents are carboxyvinyl polymers, carrageenan,hydroxyethyl cellulose, laponite and water soluble salts of celluloseethers such as sodium carboxymethylcellulose and sodium carboxymethylhydroxyethyl cellulose. Natural gums such as gum karaya, xanthan gum,gum arabic, and gum tragacanth can also be used. Colloidal magnesiumaluminum silicate or finely divided silica can be used as part of thethickening agent to further improve texture.

A preferred class of thickening or gelling agents includes a class ofhomopolymers of acrylic acid crosslinked with an alkyl ether ofpentaerythritol or an alkyl ether of sucrose, or carbomers. Carbomersare commercially available from B. F. Goodrich as the Carbopol® series.Particularly preferred Carbopols include Carbopol 934, 940, 941, 956,and mixtures thereof.

Copolymers of lactide and glycolide monomers, the copolymer having themolecular weight in the range of from about 1,000 to about 120,000(number average), are useful for delivery of actives into theperiodontal pockets or around the periodontal pockets as a “subgingivalgel carrier.” These polymers are described in U.S. Pat. Nos. 5,198,220,and 5,242,910, issued Mar. 30, 1993 and Sep. 7, 1993, respectively bothto Damani, and U.S. Pat. No. 4,443,430, issued Apr. 17, 1984 to Mattei.

Thickening agents in an amount from about 0.1% to about 15%, preferablyfrom about 2% to about 10%, more preferably from about 4% to about 8%,by weight of the total toothpaste or gel composition, can be used.Higher concentrations can be used for chewing gums, lozenges (includingbreath mints), sachets, non-abrasive gels and subgingival gels.

Humectants:

Another optional component of the topical, oral carriers of thecompositions of the present disclosure is a humectant. The humectantserves to keep toothpaste compositions from hardening upon exposure toair, to give compositions a moist feel to the mouth, and, for particularhumectants, to impart desirable sweetness of flavor to toothpastecompositions. The humectant, on a pure humectant basis, generallycomprises from about 0% to about 70%, preferably from about 5% to about25%, by weight of the compositions herein. Suitable humectants for usein compositions of the present disclosure include edible polyhydricalcohols such as glycerin, sorbitol, xylitol, butylene glycol,polyethylene glycol, and propylene glycol, especially sorbitol andglycerin.

Flavoring and Sweetening Agents:

Flavoring agents can also be added to the compositions. Suitableflavoring agents include oil of wintergreen, oil of peppermint, oil ofspearmint, clove bud oil, menthol, anethole, methyl salicylate,eucalyptol, cassia, 1-menthyl acetate, sage, eugenol, parsley oil,oxanone, alpha-irisone, marjoram, lemon, orange, propenyl guaethol,cinnamon, vanillin, thymol, linalool, cinnamaldehyde glycerol acetalknown as CGA, and mixtures thereof. Flavoring agents are generally usedin the compositions at levels of from about 0.001% to about 5%, byweight of the composition.

Sweetening agents which can be used include sucrose, glucose, saccharin,dextrose, levulose, lactose, mannitol, sorbitol, fructose, maltose,xylitol, saccharin salts, thaumatin, aspartame, D-tryptophan,dihydrochalcones, acesulfame and cyclamate salts, especially sodiumcyclamate and sodium saccharin, and mixtures thereof. A compositionpreferably contains from about 0.1% to about 10% of these agents,preferably from about 0.1% to about 1%, by weight of the composition.

In addition to flavoring and sweetening agents, coolants, salivatingagents, warming agents, and numbing agents can be used as optionalingredients in compositions of the present disclosure. These agents arepresent in the compositions at a level of from about 0.001% to about10%, preferably from about 0.1% to about 1%, by weight of thecomposition.

The coolant can be any of a wide variety of materials. Included amongsuch materials are carboxamides, menthol, ketals, diols, and mixturesthereof. Preferred coolants in the present compositions are theparamenthan carboxyamide agents such as N-ethyl-p-menthan-3-carboxamide,known commercially as “WS-3”, N,2,3-trimethyl-2-isopropylbutanamide,known as “WS-23,” and mixtures thereof. Additional preferred coolantsare selected from the group consisting of menthol,3-1-menthoxypropane-1,2-diol known as TK-10 manufactured by Takasago,menthone glycerol acetal known as MGA manufactured by Haarmann andReimer, and menthyl lactate known as Frescolat® manufactured by Haarmannand Reimer. The terms menthol and menthyl as used herein include dextro-and levorotatory isomers of these compounds and racemic mixturesthereof. TK-10 is described in U.S. Pat. No. 4,459,425, Amano et al.,issued Jul. 10, 1984. WS-3 and other agents are described in U.S. Pat.No. 4,136,163, Watson, et al., issued Jan. 23, 1979.

Preferred salivating agents of the present disclosure include Jambu®manufactured by Takasago. Preferred warming agents include capsicum andnicotinate esters, such as benzyl nicotinate. Preferred numbing agentsinclude benzocaine, lidocaine, clove bud oil, and ethanol.

Alkali Metal Bicarbonate Salt:

The present disclosure may also include an alkali metal bicarbonatesalt. Alkali metal bicarbonate salts are soluble in water and unlessstabilized, tend to release carbon dioxide in an aqueous system. Sodiumbicarbonate, also known as baking soda, is the preferred alkali metalbicarbonate salt. The present composition may contain from about 0.5% toabout 30%, preferably from about 0.5% to about 15%, and most preferablyfrom about 0.5% to about 5% of an alkali metal bicarbonate salt.

Miscellaneous Carriers:

Water employed in the preparation of commercially suitable oralcompositions should preferably be of low ion content and free of organicimpurities. Water generally comprises from about 5% to about 70%, andpreferably from about 20% to about 50%, by weight of the aqueouscompositions herein. These amounts of water include the free water whichis added plus that which is introduced with other materials, such aswith sorbitol.

Titanium dioxide may also be added to the present composition. Titaniumdioxide is a white powder which adds opacity to the compositions.Titanium dioxide generally comprises from about 0.25% to about 5% byweight of the dentifrice compositions.

The pH of the present compositions is preferably adjusted through theuse of buffering agents. Buffering agents, as used herein, refer toagents that can be used to adjust the pH of the compositions to a rangeof about pH 4.0 to about pH 10.0. Buffering agents include monosodiumphosphate, trisodium phosphate, sodium hydroxide, sodium carbonate,sodium acid pyrophosphate, citric acid, and sodium citrate. Bufferingagents can be administered at a level of from about 0.5% to about 10%,by weight of the present compositions.

Other optional agents that may be used in the present compositionsinclude dimethicone copolyols selected from alkyl- andalkoxy-dimethicone copolyols, such as C12 to C20 alkyl dimethiconecopolyols and mixtures thereof. Highly preferred is cetyl dimethiconecopolyol marketed under the Trade Name Abil EM90. The dimethiconecopolyol is generally present in a level of from about 0.01% to about25%, preferably from about 0.1% to about 5%, more preferably from about0.5% to about 1.5% by weight. The dimethicone copolyols aid in providingpositive tooth feel benefits.

Other useful carriers include biphasic dentifrice formulations such asthose disclosed in U.S. Pat. No. 5,213,790, issued May 23, 1993, U.S.Pat. No. 5,145,666, issued Sep. 8, 1992, and U.S. Pat. No. 5,281,410issued Jan. 25, 1994 all to Lukacovic et al. and in U.S. Pat. Nos.4,849,213 and 4,528,180 to Schaeffer.

Other Active Agents:

The present disclosure may also include other agents, such asantimicrobial agents. Included among such agents are water insolublenon-cationic antimicrobial agents such as halogenated diphenyl ethers,phenolic compounds including phenol and its homologs, mono andpoly-alkyl and aromatic halophenols, resorcinol and its derivatives,bisphenolic compounds and halogenated salicylanilides, benzoic esters,and halogenated carbanilides. The water soluble antimicrobials includequaternary ammonium salts and bis-biquanide salts, among others.Triclosan monophosphate is an additional water soluble antimicrobialagent. The quaternary ammonium agents include those in which one or twoof the substitutes on the quaternary nitrogen has a carbon chain length(typically alkyl group) from about 8 to about 20, typically from about10 to about 18 carbon atoms while the remaining substitutes (typicallyalkyl or benzyl group) have a lower number of carbon atoms, such as fromabout 1 to about 7 carbon atoms, typically methyl or ethyl groups.Dodecyl trimethyl ammonium bromide, tetradecylpyridinium chloride,domiphen bromide, N-tetradecyl-4-ethyl pyridinium chloride, dodecyldimethyl (2-phenoxyethyl) ammonium bromide, benzyl dimethylstearylammonium chloride, cetyl pyridinium chloride, quaternized5-amino-1,3-bis(2-ethyl-hexyl)-5-methyl hexa hydropyrimidine,benzalkonium chloride, benzethonium chloride and methyl benzethoniumchloride are exemplary of typical quaternary ammonium antibacterialagents. Other compounds are bis[4-(R-amino)-1-pyridinium]alkanes asdisclosed in U.S. Pat. No. 4,206,215, issued Jun. 3, 1980, to Bailey.Other antimicrobials such as copper bisglycinate, copper glysinate, zinccitrate, and zinc lactate may also be included. Also useful are enzymes,including endoglycosidase, papain, dextranase, mutanase, and mixturesthereof. Such agents are disclosed in U.S. Pat. No. 2,946,725, Jul. 26,1960, to Norris et al. and in U.S. Pat. No. 4,051,234, Sep. 27, 1977 toGieske et al. Specific antimicrobial agents include chlorhexidine,triclosan, triclosan monophosphate, and flavor oils such as thymol.Triclosan and other agents of this type are disclosed in Parran, Jr. etal., U.S. Pat. No. 5,015,466, issued May 14, 1991, and U.S. Pat. No.4,894,220, Jan. 16, 1990 to Nabi et al. These agents, which provideanti-plaque benefits, may be present at levels of from about 0.01% toabout 5.0%, by weight of the dentifrice composition.

Method of Use:

The present disclosure also relates to methods for cleaning andpolishing teeth and reducing the incidence of stain, plaque, gingivitisand calculus on dental enamel while also minimizing damage to the gums.

The method of use herein comprises contacting a subject's dental enamelsurfaces and oral mucosa with the oral compositions according to thepresent disclosure. The method of use may be by brushing with adentifrice, rinsing with a dentifrice slurry or mouth rinse, or chewinga gum product. Other methods include contacting the topical oral gel,mouth spray, or other form with the subject's teeth and oral mucosa. Thesubject is any person or lower animal whose tooth surface contacts theoral composition.

It should be understood that the present disclosure relates not only tomethods for delivering the present compositions to the oral cavity of ahuman, but also to methods of delivering these compositions to the oralcavity of other animals, e.g., household pets or other domestic animals,or animals kept in captivity.

For example, a method of use may include brushing a dog's teeth with oneof the dentifrice compositions. Another example would include therinsing of a cat's mouth with an oral composition for a sufficientamount of time to see a benefit. Pet care products such as chews andtoys may be formulated to contain the present oral compositions. Thecomposition including the present copolymer is incorporated into arelatively supple but strong and durable material such as rawhide, ropesmade from natural or synthetic fibers, and polymeric articles made fromnylon, polyester or thermoplastic polyurethane. As the animal chews,licks or gnaws the product, the incorporated active elements arereleased into the animal's oral cavity into a salivary medium,comparable to an effective brushing or rinsing.

Additional Aspects of the Disclosed Embodiments

In accordance with the aspects of the disclosed embodiment, a dentalcleaning composition is provided. The dental cleaning compositionincludes a substantially stoichiometric ratio of one or more oxidizingagents to one or more reducing agents in one or more orally acceptablecarriers, wherein the substantially stoichiometric ratio of one or moreoxidizing agents to one or more reducing agents is sufficient toneutralize the oxidizing agent in a subject oral cavity, and wherein theone or more oxidizing agents and one or more reducing agents are eitherco-dispensed or sequentially dispensed in the subject oral cavity.

In accordance with a first aspect of the dental cleaning composition theone or more oxidizing agents are chosen from potassium, ammonium,sodium, peroxides, metal chlorites, perborates, percarbonates,peroxyacids, persulfates, sodium pyrophosphate peroxyhydrate andcombinations thereof.

In accordance with the first aspect of the dental cleaning compositionthe peroxides are chosen from hydrogen peroxide, urea peroxide andcalcium peroxide.

In accordance with the first aspect of the dental cleaning compositionthe metal chlorites are chosen from calcium chlorite, barium chlorite,magnesium chlorite, lithium chlorite, sodium chlorite, and potassiumchlorite.

In accordance with the first aspect of the dental cleaning compositionthe persulfate is lithium persulfate.

In accordance with the first aspect of the dental cleaning compositionthe perforates are perborate mono- and tetrahydrates.

In accordance with a second aspect of the dental cleaning compositionthe one or more reducing agents are chosen from lithium aluminiumhydride, nascent hydrogen, sodium amalgam, sodium borohydride, tin(II)chloride, bismuth compounds, sulfite compounds, hydrazine, Lindlarcatalyst, phosphites, hypophosphites, phosphorous acid, dithiothreitol,and iron(II) sulfate, antioxidant compounds and elements, andcombinations thereof.

In accordance with the second aspect of the dental cleaning compositionthe antioxidant compounds and elements are chosen from coenzyme Q10,manganese, selenium, tin, bismuth, zinc, ascorbic acid (Vitamin C),melatonin, polyphenols (gallic acid, pyrogallol, quercetin, ethylgallate, naringenin, luteolin, hesperidin, catechins), uric acid, lipoicacid, melatonin, glutathione, polyphenols, α-tocopherols andtocotrienols (Vitamin E), thiols, Vitamin A (retinol), carotenes,Vitamin D, ubiquinol (coenzyme Q), propyl gallate (PG, E310), tertiarybutylhydroquinone (TBHQ), butylated hydroxyanisole (BHA, E320),butylated hydroxytoluene (BHT, E321), catechins, rosmarinic acid,cynarin, cyanidin 3-O-β-glucopyranoside, echinacoside, puerarin,oleuropein and combinations thereof.

In accordance with the second aspect of the dental cleaning compositionthe antioxidant compounds and elements are chosen from lemon peelpowder, grapefruit peel powder, melon peel powder, honeydew peel powder,pomegranate peel powder, and papaya peel powder and combinationsthereof. It is noted that the antioxidant compounds and elements mayalso function as abrasive and/or cleaning agents. It is further notedthat the abrasive agents may have a Mohs hardness ranging from 1.5 to2.5.

In accordance with the second aspect of the dental cleaning compositionthe antioxidant compounds and elements are dried fruits chosen fromraisin, fig, dates, blueberry, cranberry, blackberry, prune, raspberry,strawberry, apple, pecan, cherry, plum, pear, guava, mango, grapes,blackcurrant, orange, peach, cantaloupe, apricots, kiwi, andcombinations thereof.

In accordance with the second aspect of the dental cleaning compositionthe antioxidant compounds and elements are dried vegetables chosen frombeet, red pepper, eggplant, brussels sprout, broccoli, cabbage,mushroom, asparagus, green pepper, cauliflower, spinach, carrot, chilepepper, sweet potato, radish, yellow onion, lettuce, potato, sweet corn,white onion, squash, celery, zucchini, romaine lettuce, green pea,beetroot, avocado, green, bean, cucumber, broccoli rape, corn, garlic,kale, iceberg lettuce, leaf lettuce, broccoli flowers, artichoke,alfalfa sprouts, cherry-tomato, chive, red bean, kidney bean, blackbean, pinto bean, russet potato, asparagus, and combinations thereof.

In accordance with the second aspect of the dental cleaning compositionthe antioxidant compounds and elements are herbal botanical extractschosen from green tea, black tea and combinations thereof.

In accordance with the second aspect of the dental cleaning compositionthe antioxidant compounds and elements are chosen from carotenoidterpenoids, flavonoid polyphenolics (flavones, flavonols, flavanones,flavanols and their polymers, isoflavone phytoestrogens, stilbenoids andanthocyanins), phenolic acids and their esters, other nonflavonoidphenolics, and other potential organic antioxidants, and combinationsthereof.

In accordance with the second aspect of the dental cleaning compositionthe antioxidant compounds and elements are chosen from nuts, spices,herbs and combinations thereof. It is noted that the nuts are chosenfrom pecans, walnuts, hazelnuts, pistachio, almond, cashew nut,macadamia nut, peanuts and combinations thereof. It is noted that thespices are chosen from clove, cinnamon, oregano, turmeric, cumin,parsley, basil, curry powder, mustard seed, ginger, pepper, chilipowder, paprika, garlic, coriander, onion, cardamom, and combinationsthereof. It is noted that the herbs are chosen from sage, thyme,marjoram, tarragon, peppermint, oregano, savory, basil, dill weed andcombinations thereof.

In accordance with a third aspect of the dental cleaning composition theone or more orally acceptable carriers are chosen from abrasives,surfactants, anticalculus agents, chelating agents, fluoride sources,thickening agents, humectants, alkali metal bicarbonate salt,miscellaneous carriers, other active agents and combinations thereof. Itis noted that the abrasives are chosen from carbonates, pyrophosphates,polylimones, cuteins, suberins and combinations thereof. It is notedthat the abrasives have a Mohs hardness ranging from 1.5 to 5.0. It isnoted that the abrasives also function as antioxidant compounds.

In accordance with a fourth aspect of the dental cleaning compositionthe composition is in the form of chosen from a toothpaste, dentifrice,tooth powder, topical oral gel, mouth rinse, denture product, mouthspray, lozenge, oral tablet, chewing gum, impregnated dental implement,dental floss, and combinations thereof.

In accordance with the fifth aspect of the dental cleaning compositionthe composition provides enhanced cleaning, whitening and stain removalfrom teeth with minimal gum and enamel damage.

In accordance with the aspects of the disclosed embodiment, a method forcleaning teeth is provided. The method includes providing a dentalcleaning composition including a substantially stoichiometric ratio ofone or more oxidizing agents to one or more reducing agents in one ormore orally acceptable carriers, and applying the dental cleaningcomposition to a subject oral cavity in a form chosen from a toothpaste,dentifrice, tooth powder, topical oral gel, mouth rinse, dentureproduct, mouth spray, lozenge, oral tablet, or chewing gum, impregnateddental implement, dental floss, and combinations thereof, wherein thesubstantially stoichiometric ratio of one or more oxidizing agents toone or more reducing agents is sufficient to neutralize the oxidizingagent in the subject oral cavity, and wherein the one or more oxidizingagents and the one or more reducing agents of the dental cleaningcomposition are either co-dispensed or sequentially dispensed in thesubject oral cavity.

In accordance with a first aspect of the method for cleaning teeth theone or more oxidizing agents are chosen from potassium, ammonium,sodium, peroxides, metal chlorites, perborates, percarbonates,peroxyacids, persulfates, sodium pyrophosphate peroxyhydrate andcombinations thereof. It is noted that the peroxides are chosen fromhydrogen peroxide, urea peroxide and calcium peroxide. It is noted thatthe metal chlorites are chosen from calcium chlorite, barium chlorite,magnesium chlorite, lithium chlorite, sodium chlorite, and potassiumchlorite. It is noted that the persulfate is lithium persulfate. It isnoted that the perforates are perborate mono- and tetrahydrates.

In accordance with a second aspect of the method for cleaning teeth theone or more reducing agents are chosen from lithium aluminium hydride,nascent hydrogen, sodium amalgam, sodium borohydride, tin(II) chloride,bismuth compounds, sulfite compounds, hydrazine, Lindlar catalyst,phosphites, hypophosphites, phosphorous acid, dithiothreitol, andiron(II) sulfate, antioxidant compounds and elements, and combinationsthereof.

In accordance with the second aspect of the method for cleaning teeth,it is noted that the antioxidant compounds and elements are chosen fromcoenzyme Q10, manganese, selenium, tin, bismuth, zinc, ascorbic acid(Vitamin C), melatonin, polyphenols (gallic acid, pyrogallol, quercetin,ethyl gallate, naringenin, luteolin, hesperidin, catechins), uric acid,lipoic acid, melatonin, glutathione, polyphenols, α-tocopherols andtocotrienols (Vitamin E), thiols, Vitamin A (retinol), carotenes,Vitamin D, ubiquinol (coenzyme Q), propyl gallate (PG, E310), tertiarybutylhydroquinone (TBHQ), butylated hydroxyanisole (BHA, E320),butylated hydroxytoluene (BHT, E321), catechins, rosmarinic acid,cynarin, cyanidin 3-O-β-glucopyranoside, echinacoside, puerarin,oleuropein and combinations thereof.

In accordance with the second aspect of the method for cleaning teeth,it is noted that the antioxidant compounds and elements are chosen fromlemon peel powder, grapefruit peel powder, melon peel powder, honeydewpeel powder, pomegranate peel powder, and papaya peel powder andcombinations thereof. It is noted that the antioxidant compounds andelements also function as abrasive and/or cleaning agents. It is notedthat the abrasive agents have a Mohs hardness ranging from 1.5 to 2.5.

In accordance with the second aspect of the method for cleaning teeth,the antioxidant compounds and elements are dried fruits chosen fromraisin, fig, dates, blueberry, cranberry, blackberry, prune, raspberry,strawberry, apple, pecan, cherry, plum, pear, guava, mango, grapes,blackcurrant, orange, peach, cantaloupe, apricots, kiwi, andcombinations thereof.

In accordance with the second aspect of the method for cleaning teeth,the antioxidant compounds and elements are dried vegetables chosen frombeet, red pepper, eggplant, brussels sprout, broccoli, cabbage,mushroom, asparagus, green pepper, cauliflower, spinach, carrot, chilepepper, sweet potato, radish, yellow onion, lettuce, potato, sweet corn,white onion, squash, celery, zucchini, romaine lettuce, green pea,beetroot, avocado, green, bean, cucumber, broccoli rape, corn, garlic,kale, iceberg lettuce, leaf lettuce, broccoli flowers, artichoke,alfalfa sprouts, cherry-tomato, chive, red bean, kidney bean, blackbean, pinto bean, russet potato, asparagus, and combinations thereof.

In accordance with the second aspect of the method for cleaning teeth,the antioxidant compounds and elements are herbal botanical extractschosen from green tea, black tea and combinations thereof.

In accordance with the second aspect of the method for cleaning teeth,the antioxidant compounds and elements are chosen from carotenoidterpenoids, flavonoid polyphenolics (flavones, flavonols, flavanones,flavanols and their polymers, isoflavone phytoestrogens, stilbenoids andanthocyanins), phenolic acids and their esters, other nonflavonoidphenolics, and other potential organic antioxidants, and combinationsthereof.

In accordance with the second aspect of the method for cleaning teeth,the antioxidant compounds and elements are chosen from nuts, spices,herbs and combinations thereof. It is noted that the nuts are chosenfrom pecans, walnuts, hazelnuts, pistachio, almond, cashew nut,macadamia nut, peanuts and combinations thereof. It is noted that thespices are chosen from clove, cinnamon, oregano, turmeric, cumin,parsley, basil, curry powder, mustard seed, ginger, pepper, chilipowder, paprika, garlic, coriander, onion, cardamom, and combinationsthereof. It is noted that the herbs are chosen from sage, thyme,marjoram, tarragon, peppermint, oregano, savory, basil, dill weed andcombinations thereof.

In accordance with a third aspect of the method for cleaning teeth theone or more orally acceptable carriers are chosen from abrasives,surfactants, anticalculus agents, chelating agents, fluoride sources,thickening agents, humectants, alkali metal bicarbonate salt,miscellaneous carriers, other active agents and combinations thereof.

In accordance with the third aspect of the method for cleaning teeth theabrasives are chosen from carbonates, pyrophosphates, polylimones,cuteins, suberins and combinations thereof. It is noted that theabrasives have a Mohs hardness ranging from 1.5 to 5.0. It is noted thatthe abrasives also function as antioxidant compounds.

In accordance with a fourth aspect of the method for cleaning teeth themethod provides enhanced cleaning, whitening and stain removal fromteeth with minimal gum and enamel damage.

In accordance with the aspects of the disclosed embodiment, a method ofmaking a dental cleaning composition is provided. The method includesproviding a substantially stoichiometric ratio of one or more oxidizingagents, one or more reducing agents, and one or more orally acceptablecarriers, mixing the one or more oxidizing agents into one or moreorally acceptable carriers, mixing the one or more reducing agents intoone or more orally acceptable carriers, and combining the mixture of theone or more oxidizing agents in one or more orally acceptable carriersand the mixture of the one or more reducing agents in one or more orallyacceptable carriers in a form for either co-dispensing or sequentiallydispensing in a subject oral cavity, wherein the substantiallystoichiometric ratio of one or more oxidizing agents to one or morereducing agents is sufficient to neutralize the oxidizing agent in thesubject oral cavity, and wherein the form for either co-dispensing orsequentially dispensing the dental cleaning composition to the subjectoral cavity is chosen from a toothpaste, dentifrice, tooth powder,topical oral gel, mouth rinse, denture product, mouth spray, lozenge,oral tablet, or chewing gum, impregnated dental implement, dental floss,and combinations thereof.

In accordance with a first aspect of the method of making a dentalcleaning composition the one or more oxidizing agents are chosen frompotassium, ammonium, sodium, peroxides, metal chlorites, perborates,percarbonates, peroxyacids, persulfates, sodium pyrophosphateperoxyhydrate and combinations thereof.

In accordance with the first aspect of the method of making a dentalcleaning composition the peroxides are chosen from hydrogen peroxide,urea peroxide and calcium peroxide. It is noted that the metal chloritesare chosen from calcium chlorite, barium chlorite, magnesium chlorite,lithium chlorite, sodium chlorite, and potassium chlorite. It is notedthat the persulfate is lithium persulfate. It is noted that theperforates are perborate mono- and tetrahydrates.

In accordance with a second aspect of the method of making a dentalcleaning composition the one or more reducing agents are chosen fromlithium aluminium hydride, nascent hydrogen, sodium amalgam, sodiumborohydride, tin(II) chloride, bismuth compounds, sulfite compounds,hydrazine, zinc-mercury amalgam, Lindlar catalyst, oxalic acid, formicacid, phosphites, hypophosphites, phosphorous acid, dithiothreitol, andiron(II) sulfate, antioxidant compounds and elements, and combinationsthereof.

In accordance with the second aspect of the method of making a dentalcleaning composition the antioxidant compounds and elements are chosenfrom coenzyme Q10, manganese, tin, bismuth, selenium, zinc, ascorbicacid (Vitamin C), melatonin, polyphenols (gallic acid, pyrogallol,quercetin, ethyl gallate, naringenin, luteolin, hesperidin, catechins),uric acid, lipoic acid, melatonin, glutathione, polyphenols,α-tocopherols and tocotrienols (Vitamin E), thiols, Vitamin A (retinol),carotenes, Vitamin D, ubiquinol (coenzyme Q), propyl gallate (PG, E310),tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole (BHA, E320),butylated hydroxytoluene (BHT, E321), catechins, rosmarinic acid,cynarin, cyanidin 3-O-β-glucopyranoside, echinacoside, puerarin,oleuropein and combinations thereof.

In accordance with the second aspect of the method of making a dentalcleaning composition the antioxidant compounds and elements are chosenfrom lemon peel powder, grapefruit peel powder, melon peel powder,honeydew peel powder, pomegranate peel powder, and papaya peel powderand combinations thereof. It is noted that the antioxidant compounds andelements also function as abrasive and/or cleaning agents. It is notedthat the abrasive agents have a Mohs hardness ranging from 1.5 to 2.5.

In accordance with the second aspect of the method of making a dentalcleaning composition the antioxidant compounds and elements are driedfruits chosen from raisin, fig, dates, blueberry, cranberry, blackberry,prune, raspberry, strawberry, apple, pecan, cherry, plum, pear, guava,mango, grapes, blackcurrant, orange, peach, cantaloupe, apricots, kiwi,and combinations thereof.

In accordance with the second aspect of the method of making a dentalcleaning composition the antioxidant compounds and elements are driedvegetables chosen from beet, red pepper, eggplant, brussels sprout,broccoli, cabbage, mushroom, asparagus, green pepper, cauliflower,spinach, carrot, chile pepper, sweet potato, radish, yellow onion,lettuce, potato, sweet corn, white onion, squash, celery, zucchini,romaine lettuce, green pea, beetroot, avocado, green, bean, cucumber,broccoli rape, corn, garlic, kale, iceberg lettuce, leaf lettuce,broccoli flowers, artichoke, alfalfa sprouts, cherry-tomato, chive, redbean, kidney bean, black bean, pinto bean, russet potato, asparagus, andcombinations thereof.

In accordance with the second aspect of the method of making a dentalcleaning composition the antioxidant compounds and elements are herbalbotanical extracts chosen from green tea, black tea and combinationsthereof.

In accordance with the second aspect of the method of making a dentalcleaning composition the antioxidant compounds and elements are chosenfrom carotenoid terpenoids, flavonoid polyphenolics (flavones,flavonols, flavanones, flavanols and their polymers, isoflavonephytoestrogens, stilbenoids and anthocyanins), phenolic acids and theiresters, other nonflavonoid phenolics, and other potential organicantioxidants, and combinations thereof.

In accordance with the second aspect of the method of making a dentalcleaning composition the antioxidant compounds and elements are chosenfrom nuts, spices, herbs and combinations thereof. It is noted that thenuts are chosen from pecans, walnuts, hazelnuts, pistachio, almond,cashew nut, macadamia nut, peanuts and combinations thereof. It is notedthat the spices are chosen from clove, cinnamon, oregano, turmeric,cumin, parsley, basil, curry powder, mustard seed, ginger, pepper, chilipowder, paprika, garlic, coriander, onion, cardamom, and combinationsthereof. It is noted that the herbs are chosen from sage, thyme,marjoram, tarragon, peppermint, oregano, savory, basil, dill weed andcombinations thereof.

In accordance with a third aspect of the method of making a dentalcleaning composition the one or more one or more orally acceptablecarriers are chosen from abrasives, surfactants, anticalculus agents,chelating agents, fluoride sources, thickening agents, humectants,alkali metal bicarbonate salt, miscellaneous carriers, other activeagents and combinations thereof.

In accordance with the third aspect of the method of making a dentalcleaning composition the abrasives are chosen from carbonates,pyrophosphates, polylimones, cuteins, suberins and combinations thereof.It is noted that the abrasives have a Mohs hardness ranging from 1.5 to5.0. It is noted that the abrasives also function as antioxidantcompounds.

In accordance with a fourth aspect of the method of making a dentalcleaning composition the method provides enhanced cleaning, whiteningand stain removal from teeth with minimal gum and enamel damage.

In accordance with the aspect of the disclosed embodiment, a dentalcleaning composition is provided. The composition includes 0.5 to 90 wt.% of one or more reducing agents in one or more orally acceptablecarriers, wherein the one or more reducing agents are chosen from foodgrade antioxidants.

In accordance with a first aspect of the dental cleaning composition theone or more food grade antioxidants are chosen from coenzyme Q10,manganese, tin, bismuth, selenium, zinc, ascorbic acid (Vitamin C),melatonin, polyphenols (gallic acid, pyrogallol, quercetin, ethylgallate, naringenin, luteolin, hesperidin, catechins), uric acid, lipoicacid, melatonin, glutathione, polyphenols, α-tocopherols andtocotrienols (Vitamin E), thiols, Vitamin A (retinol), carotenes,Vitamin D, ubiquinol (coenzyme Q), propyl gallate (PG, E310), tertiarybutylhydroquinone (TBHQ), butylated hydroxyanisole (BHA, E320),butylated hydroxytoluene (BHT, E321), catechins, rosmarinic acid,cynarin, cyanidin 3-O-β-glucopyranoside, echinacoside, puerarin,oleuropein and combinations thereof.

In accordance with a second aspect of the dental cleaning compositionthe one or more food grade antioxidants are chosen from lemon peelpowder, grapefruit peel powder, melon peel powder, honeydew peel powder,pomegranate peel powder, and papaya peel powder and combinationsthereof.

In accordance with the second aspect of the dental cleaning compositionthe one or more food grade antioxidants function as abrasive and/orcleaning agents. It is noted that the abrasive agents have a Mohshardness ranging from 1.5 to 2.5.

In accordance with a third aspect of the dental cleaning composition theone or more food grade antioxidants are dried fruits chosen from raisin,fig, dates, blueberry, cranberry, blackberry, prune, raspberry,strawberry, apple, pecan, cherry, plum, pear, guava, mango, grapes,blackcurrant, orange, peach, cantaloupe, apricots, kiwi, andcombinations thereof.

In accordance with a fourth aspect of the dental cleaning compositionthe one or more food grade antioxidants are dried vegetables chosen frombeet, red pepper, eggplant, brussels sprout, broccoli, cabbage,mushroom, asparagus, green pepper, cauliflower, spinach, carrot, chilipepper, sweet potato, radish, yellow onion, lettuce, potato, sweet corn,white onion, squash, celery, zucchini, romaine lettuce, green pea,beetroot, avocado, green, bean, cucumber, broccoli rape, corn, garlic,kale, iceberg lettuce, leaf lettuce, broccoli flowers, artichoke,alfalfa sprouts, cherry-tomato, chive, red bean, kidney bean, blackbean, pinto bean, russet potato, asparagus, and combinations thereof.

In accordance with a fifth aspect of the dental cleaning composition theone or more food grade antioxidants are herbal botanical extracts chosenfrom green tea, black tea and combinations thereof.

In accordance with a sixth aspect of the dental cleaning composition theone or more food grade antioxidants are chosen from carotenoidterpenoids, flavonoid polyphenolics (flavones, flavonols, flavanones,flavanols and their polymers, isoflavone phytoestrogens, stilbenoids andanthocyanins), phenolic acids and their esters, other nonflavonoidphenolics, and other potential organic antioxidants, and combinationsthereof.

In accordance with a seventh aspect of the dental cleaning compositionthe one or more food grade antioxidants are chosen from nuts, spices,herbs and combinations thereof.

In accordance with the seventh aspect of the dental cleaning compositionthe nuts are chosen from pecans, walnuts, hazelnuts, pistachio, almond,cashew nut, macadamia nut, peanuts and combinations thereof.

In accordance with the seventh aspect of the dental cleaning compositionthe spices are chosen from clove, cinnamon, oregano, turmeric, cumin,parsley, basil, curry powder, mustard seed, ginger, pepper, chilipowder, paprika, garlic, coriander, onion, cardamom, and combinationsthereof.

In accordance with the seventh aspect of the dental cleaning compositionthe herbs are chosen from sage, thyme, marjoram, tarragon, peppermint,oregano, savory, basil, dill weed and combinations thereof.

In accordance with an eighth aspect of the dental cleaning compositionthe one or more one or more orally acceptable carriers are chosen fromabrasives, surfactants, anticalculus agents, chelating agents, fluoridesources, thickening agents, humectants, alkali metal bicarbonate salt,miscellaneous carriers, other active agents and combinations thereof.

In accordance with the eighth aspect of the dental cleaning compositionthe abrasives are chosen from carbonates, pyrophosphates, polylimones,cuteins, suberins and combinations thereof. It is noted that theabrasives have a Mohs hardness ranging from 1.5 to 5.0. It is noted thatthe abrasives also function as antioxidant compounds.

In accordance with a ninth aspect of the dental cleaning composition thecomposition is in the form of chosen from a toothpaste, dentifrice,tooth powder, topical oral gel, mouth rinse, denture product, mouthspray, lozenge, oral tablet, chewing gum, impregnated dental implement,dental floss, and combinations thereof.

In accordance with a tenth aspect of the dental cleaning composition thecomposition provides enhanced cleaning, whitening and stain removal fromteeth with minimal gum and enamel damage.

It is noted, as can be seen above, that the embodiments provide dentalcleaning compositions, methods of using and methods of using suchcompositions which minimize gum damage in the oral cavity. In one form,the dental cleaning composition includes a substantially stoichiometricratio of one or more oxidizing agents to one or more reducing agents inone or more one or more orally acceptable carriers; where thesubstantially stoichiometric ratio of one or more oxidizing agents toone or more reducing agents is sufficient to neutralize the oxidizingagent in a subject oral cavity; and where the one or more oxidizingagents and one or more reducing agents are either co-dispensed orsequentially dispensed in the subject oral cavity.

The following examples will more fully illustrate the embodiments of thepresent disclosure and are not to be construed as limiting. All parts,percentages and proportions referred to herein and in the appendedclaims are by weight of the total composition unless otherwise stated.

EXAMPLES Example 1

This example provides illustrative compositions of a first compositionwhich is a viscous gel and a second composition which is a dispersion oflemon dust powder in glycerine. The two compositions may be co-dispensedor sequentially dispensed.

The first oxidizing composition components include 88 wt. % water,Poloxamer 407 5.0 wt. %, hydrogen peroxide at 3 wt. %, glycerin at 3 wt.%, and a sufficient amount to make a total of 100 wt. % of phosphoricacid/water (q.s.). The viscosity of the first oxidizing composition isgreater than 250,000 cP with a pH equal to 4.0. The first composition isin the form of a peroxide gel or cream.

The second reducing composition components include 32 wt. % lemon peeldust and 67 wt. % glycerine, water/sodium hydroxide solution (q.s,) in arinse or gel form. The pH of the second composition is 4.5-5.0.

Example 2

Example 2 provides an illustrative composition of a viscous gel which isfirst applied to the gums for protection and is illustrative ofsequential dispensing of oxidizing agent and reducing agent.

The first composition applied to the gums for protection includes 68 wt.% glycerine and 32 wt. % grape fruit peel powder.

The second composition is a professionally applied 30 wt. % hydrogenperoxide solution for dental office application in a rinse/liquid form.The pH of the rinse is buffered to 4-5. The sequential dispensing helpsprevent sensitization of the subject's gums.

Example 3

Example 3 provides an illustrative composition of a mouth rinse whichmost preferably post applied after brightening with tooth whiteningtoothpaste. It could however be applied before brushing with a toothwhitening toothpaste.

The composition includes sorbitol solution in water (88 wt. %/12 wt. %)and 60 wt % of total composition, ascorbic acid at 5 wt. %, ascorbylglycoside at 5 wt. %, propylene glycol at 25 wt. %, and water at 5 wt.%. The pH of the subject oral cavity after brushing and before rinsingwith the above composition is 7 to 9. The pH of the subject oral cavityafter brushing and rinsing with the above composition is 4 to 7.

Example 4

This example provides an example of an antioxidant toothpaste combininghigh levels antioxidant type abrasives and regular type abrasives.

The first composition includes 68 wt. % glycerine and 32 wt. % lemonpeel dust (antioxidant abrasive composition).

The second composition include 10 wt. % sodium bicarbonate, 35 wt. %sorbitol, 3 wt. % sodium lauryl sulfate, 0.8 wt. % cellulose gum, 0.5wt. % menthol. 0.3 wt % sodium fluoride and a sufficient amount to makea total of 100 wt. % of water (q.s.) (regular abrasive composition).

According to the present disclosure, an advantageous dental cleaningcomposition comprises a substantially stoichiometric ratio of one ormore oxidizing agents to one or more reducing agents in one or more oneor more orally acceptable carriers; wherein the substantiallystoichiometric ratio of one or more oxidizing agents to one or morereducing agents is sufficient to neutralize the oxidizing agent in asubject oral cavity; and wherein the one or more oxidizing agents andone or more reducing agents are either co-dispensed or sequentiallydispensed in the subject oral cavity. The resulting pH in the oralcavity will be in the range of 4 to 8.

Another aspect of the present disclosure relates to an advantageousdental cleaning composition comprising: 0.5 to 90 wt. % of one or morereducing agents in one or more orally acceptable carriers, wherein theone or more reducing agents are chosen from good grade antioxidants.

A further aspect of the present disclosure relates to an advantageousmethod for cleaning teeth comprising: providing a dental cleaningcomposition including a substantially stoichiometric ratio of one ormore oxidizing agents to one or more reducing agents in one or moreorally acceptable carriers; and applying the dental cleaning compositionto a subject oral cavity in a form chosen from a toothpaste, dentifrice,tooth powder, topical oral gel, mouth rinse, denture product, mouthspray, lozenge, oral tablet, or chewing gum, impregnated dentalimplement, dental floss, and combinations thereof; wherein thesubstantially stoichiometric ratio of one or more oxidizing agents toone or more reducing agents is sufficient to neutralize the oxidizingagent in the subject oral cavity; and wherein the one or more oxidizingagents and the one or more reducing agents of the dental cleaningcomposition are either co-dispensed or sequentially dispensed in thesubject oral cavity.

Another aspect of the present disclosure relates to an advantageousmethod of making a dental cleaning composition comprising: providing asubstantially stoichiometric ratio of one or more oxidizing agents, oneor more reducing agents, and one or more orally acceptable carriers;mixing the one or more oxidizing agents into one or more orallyacceptable carriers; mixing the one or more reducing agents into one ormore orally acceptable carriers; and combining the mixture of the one ormore oxidizing agents in one or more orally acceptable carriers and themixture of the one or more reducing agents in one or more orallyacceptable carriers in a form for either co-dispensing or sequentiallydispensing in a subject oral cavity; wherein the substantiallystoichiometric ratio of one or more oxidizing agents to one or morereducing agents is sufficient to neutralize the oxidizing agent in thesubject oral cavity; and wherein the form for either co-dispensing orsequentially dispensing the dental cleaning composition to the subjectoral cavity is chosen from a toothpaste, dentifrice, tooth powder,topical oral gel, mouth rinse, denture product, mouth spray, lozenge,oral tablet, or chewing gum, impregnated dental implement, dental floss,and combinations thereof.

These and other features and attributes of the disclosed dental cleaningcompositions and methods of making the dental cleaning compositions ofthe present disclosure and their advantageous applications and/or useswill be apparent from the detailed description which follows,particularly when read in conjunction with the enclosed examples.

Applicants have attempted to disclose all embodiments and applicationsof the disclosed subject matter that could be reasonably foreseen.However, there may be unforeseeable, insubstantial modifications thatremain as equivalents. While the present disclosure has been describedin conjunction with specific, exemplary embodiments thereof, it isevident that many alterations, modifications, and variations will beapparent to those skilled in the art in light of the foregoingdescription without departing from the spirit or scope of the presentdisclosure. Accordingly, the present disclosure is intended to embraceall such alterations, modifications, and variations of the abovedetailed description.

All patents, test procedures, and other documents cited herein,including priority documents, are fully incorporated by reference to theextent such disclosure is not inconsistent with this disclosure and forall jurisdictions in which such incorporation is permitted.

When numerical lower limits and numerical upper limits are listedherein, ranges from any lower limit to any upper limit are contemplated.

It should be understood that the foregoing description is onlyillustrative of the embodiments. Various alternatives and modificationscan be devised by those skilled in the art without departing from theembodiments. Accordingly, the present embodiments are intended toembrace all such alternatives, modifications and variances that fallwithin the scope of the appended claims.

What is claimed is:
 1. A dental cleaning composition comprising: 0.5 to90 wt. % of one or more reducing agents in one or more orally acceptablecarriers, wherein the one or more reducing agents are chosen from one ormore food grade antioxidants.
 2. The composition of claim 1, wherein theone or more food grade antioxidants are chosen from coenzyme Q10,manganese, iodide selenium, zinc, ascorbic acid (Vitamin C), melatonin,polyphenols (gallic acid, pyrogallol, quercetin, ethyl gallate,naringenin, luteolin, hesperidin, catechins), uric acid, lipoic acid,melatonin, glutathione, polyphenols, α-tocopherols and tocotrienols(Vitamin E), thiols, Vitamin A (retinol), carotenes, Vitamin D,ubiquinol (coenzyme Q), propyl gallate (PG, E310), tertiarybutylhydroquinone (TBHQ), butylated hydroxyanisole (BHA, E320),butylated hydroxytoluene (BHT, E321), catechins, rosmarinic acid,cynarin, cyanidin 3-O-β-glucopyranoside, echinacoside, puerarin,oleuropein and combinations thereof.
 3. The composition of claim 1, theone or more food grade antioxidants are chosen from lemon peel powder,grapefruit peel powder, melon peel powder, honeydew peel powder,pomegranate peel powder, and papaya peel powder and combinationsthereof.
 4. The composition of claim 3, wherein the one or more foodgrade antioxidants function as abrasive and/or cleaning agents.
 5. Thecomposition of claim 4, wherein the abrasive agents have a Mohs hardnessranging from 1.5 to 2.5.
 6. The composition of claim 1, wherein the oneor more food grade antioxidants are dried fruits chosen from raisin,fig, dates, blueberry, cranberry, blackberry, prune, raspberry,strawberry, apple, pecan, cherry, plum, pear, guava, mango, grapes,blackcurrant, orange, peach, cantaloupe, apricots, kiwi, andcombinations thereof.
 7. The composition of claim 1, wherein the one ormore food grade antioxidants are dried vegetables chosen from beet, redpepper, eggplant, brussels sprout, broccoli, cabbage, mushroom,asparagus, green pepper, cauliflower, spinach, carrot, chile pepper,sweet potato, radish, yellow onion, lettuce, potato, sweet corn, whiteonion, squash, celery, zucchini, romaine lettuce, green pea, beetroot,avocado, green, bean, cucumber, broccoli rape, corn, garlic, kale,iceberg lettuce, leaf lettuce, broccoli flowers, artichoke, alfalfasprouts, cherry-tomato, chive, red bean, kidney bean, black bean, pintobean, russet potato, asparagus, and combinations thereof.
 8. Thecomposition of claim 1, wherein the one or more food grade antioxidantsare herbal botanical extracts chosen from green tea, black tea andcombinations thereof.
 9. The composition of claim 1, wherein the one ormore food grade antioxidants are chosen from carotenoid terpenoids,flavonoid polyphenolics (flavones, flavonols, flavanones, flavanols andtheir polymers, isoflavone phytoestrogens, stilbenoids andanthocyanins), phenolic acids and their esters, other nonflavonoidphenolics, and other potential organic antioxidants, and combinationsthereof.
 10. The composition of claim 1, wherein the one or more foodgrade antioxidants are chosen from nuts, spices, herbs and combinationsthereof.
 11. The composition of claim 10, wherein the nuts are chosenfrom pecans, walnuts, hazelnuts, pistachio, almond, cashew nut,macadamia nut, peanut butter and combinations thereof.
 12. Thecomposition of claim 10, wherein the spices are chosen from clove,cinnamon, oregano, turmeric, cumin, parsley, basil, curry powder,mustard seed, ginger, pepper, chili powder, paprika, garlic, coriander,onion, cardamom, and combinations thereof.
 13. The composition of claim10, wherein the herbs are chosen from sage, thyme, marjoram, tarragon,peppermint, oregano, savory, basil, dill weed and combinations thereof.14. The composition of claim 1, wherein the one or more one or moreorally acceptable carriers are chosen from abrasives, surfactants,anticalculus agents, chelating agents, fluoride sources, thickeningagents, humectants, alkali metal bicarbonate salt, miscellaneouscarriers, other active agents and combinations thereof.
 15. Thecomposition of claim 14, wherein the abrasives are chosen fromcarbonates, pyrophosphates, polylimones, cuteins, suberins andcombinations thereof.
 16. The composition of claim 15, wherein theabrasives have a Mohs hardness ranging from 1.5 to 5.0.
 17. Thecomposition of claim 16, wherein the abrasives also function asantioxidant compounds.
 18. The composition of claim 1, wherein thecomposition is in the form of chosen from a toothpaste, dentifrice,tooth powder, topical oral gel, mouth rinse, denture product, mouthspray, lozenge, oral tablet, chewing gum, impregnated dental implement,dental floss, and combinations thereof.